A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition) (T21)

This highly interactive, course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a life cycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems, and the full system life cycle from concept to retirement.

The course shows how appropriate quality risk management and specification and verification activities should be an integral part of the normal system life cycle. Many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The course promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.

Practical “hands-on” workshop exercises using a wide range of case study examples across differing systems have been included to illustrate the approach covering a wide range of systems from basic equipment and instruments to large, complex, Distributed Control Systems.

The course concentrates on the following features of the system life cycle that are special, or particularly relevant to process control systems including multiple components and multiple suppliers; interfaces to a physical process being controlled in real time, to and degree of embedding with the process equipment and interfaces introduced by phasing of delivery.

Take Back to Your Job

A comprehensive overview of current good practice for GxP regulated process control systems

Harmonized approaches for all types of process control systems

Understanding of the process control system life cycle, and discussion of the detailed engineering activities, covering:

Practical knowledge of applying the risk-based approach

Generation of accurate and complete user requirements with an early emphasis on product and process understanding

Effective collaboration between regulated companies and suppliers

Leveraging of supplier documentation

Scalability of approach based on GxP risk, GAMP categorization and other factors

Attendance Suggested for

Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance

Computer system vendors or consultants, engineering contractors, and validation service companies

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.